DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/12/2026 has been entered.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In light of the amendments, the previous 112(a) rejections have been withdrawn.
In light of the amendments, the previous 112(b) rejections have been withdrawn.
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
Notice to Applicant
In the amendment dated 08/12/2026, the following has occurred: claims 1, 4, 6, 10, and 13 have been amended; claims 2-3, 5, 7-9, 11-12, and 14 remain unchanged; and no new claims have been added.
Claims 1-14 are pending.
Effective Filing Date: 03/09/2022
Response to Arguments
35 U.S.C. 101 Rejections:
Applicant argues that the amended claims are not merely directed to evaluating data or determining whether a value falls within a range. Applicant further states that the claimed operation addresses as specific technological problem as identified in the specification, namely that conventional clinical diagnostic tests have an analytical precision inherent to the defined test method and this have essentially a fixed analytical precision. First, the claims do not reflect this statement as there is are calculations using specimen data and an order of operations depending of the values of data. Furthermore, the adjustment of a clinical precision is not necessarily a technical improvement, rather it can be seen moreover as an improvement to the abstract idea involving calculations involving analytical precision. People can adjust precision metrics, so claiming that the adjustment is being performed exclusively by a computer is applying the abstract idea using computing components.
Applicant further states that the claims are directed to a practical application under Step 2A, Prong Two as the claims as a whole applies the exception in a manner that improves another technology. Examiner however respectfully disagrees as the additional elements in this section merely apply the abstract idea using generic computing components.
Applicant further points to McRO and states that the present claims are similar. Examiner however respectfully disagrees as the present claims do provide a technical improvement in a similar manner. The technical improvement of McRO is that lip synchronization occurred for an animation, thereby improving the technical field animation. The present invention however involves the reliability of data and adjusting a value to account for maintaining this reliability. The supposed technical improvement here is to data collection? An improvement to the data can be seen as an improvement to an abstract idea. Examiner would like to emphasize that even if this were a technical improvement, the claims do not necessarily reflect this improvement.
Applicant further states that there is a change in the operation of a clinical analyzer and that the invention avoids unnecessary evaluations. The operation of the computing device here (analyzer) is not necessarily being improved by performing a different operation. The performance of these operations using a computing component (analyzer) is done so in an “apply it” manner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-9 are drawn to analyzers and claims 10-14 are drawn to a system, each of which is within the four statutory categories. Claims 1-14 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a clinical diagnostic analyzer for dynamically adjusting analytical precision in a clinical diagnostic test, comprising:
a) a processor;
b) measurement hardware in communication with the processor and configured to measure properties of an analyte;
c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising:
1) accessing a stored precision profile data file associated with the clinical diagnostic test, the precision profile data file comprising a first predetermined range and a predetermined number of re-evaluations associated with the first predetermined range;
2) loading and evaluating a patient specimen to ascertain a first value for the specimen;
3) comparing the first value to determine if the first value is within the first predetermined range;
4) upon determining the first value is within the first predetermined range, re-evaluating the patient specimen the predetermined number of times identified by the precision profile data file to determine a second value and reporting the second value to a user; and
5) upon determining the first value is not within the first predetermined range, reporting the first value to a user;
6) wherein all comparisons and re-evaluations are automatically performed without human intervention.
Claim 1 recites, in part, performing the steps of 1) accessing a stored precision profile data file associated with the clinical diagnostic test, the precision profile data file comprising a first predetermined range and a predetermined number of re-evaluations associated with the first predetermined range, 2) loading and evaluating a patient specimen to ascertain a first value for the specimen, 3) comparing the first value to determine if the first value is within the first predetermined range, 4) upon determining the first value is within the first predetermined range, re-evaluating the patient specimen the predetermined number of times identified by the precision profile data file to determine a second value and reporting the second value to a user, and 5) upon determining the first value is not within the first predetermined range, reporting the first value to a user. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes evaluating data and determining if a value is within a range or not within a range. Independent claim 10 recites similar limitations and is also directed to an abstract idea under the same analysis.
Claim 6 recites a clinical diagnostic analyzer for dynamically adjusting analytical precision in a clinical diagnostic test, comprising:
a) a processor;
b) measurement hardware in communication with the processor and configured to measure properties of an analyte;
c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising:
7) accessing a precision profile data file associated with the clinical diagnostic test, the precision profile data file comprising a first predetermined range and a predetermined number of re-evaluations associated with the first predetermined range;
8) loading and evaluating a patient specimen to ascertain a first value for the specimen;
9) comparing the first value to determine if the first value is within the first predetermined range;
10) upon determining the first value is within the first predetermined range, revaluating the patient specimen the predetermined number of times identified by the precision profile data file to determine a second value for the specimen;
11) calculating a precision value based on the first value and the second value;
12) reporting the precision value to a user;
13) wherein all operations are executed by the processor and are not performed manually.
Claim 6 recites, in part, performing the steps of 7) accessing a precision profile data file associated with the clinical diagnostic test, the precision profile data file comprising a first predetermined range and a predetermined number of re-evaluations associated with the first predetermined range, 8) loading and evaluating a patient specimen to ascertain a first value for the specimen, 9) comparing the first value to determine if the first value is within the first predetermined range, 10) upon determining the first value is within the first predetermined range, revaluating the patient specimen the predetermined number of times identified by the precision profile data file to determine a second value for the specimen, 11) calculating a precision value based on the first value and the second value, and 12) reporting the precision value to a user. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes evaluating data and determining if a value is within a range or not within a range.
Depending claims 2-5, 7-9, and 11-14 include all of the limitations of claims 1, 6, and 10, and therefore likewise incorporate the above described abstract idea. Depending claims 4, 9, and 13 add the additional step of “generating an alert to a user when the reported first value or the reported second value are within a second predetermined range”. Additionally, the limitations of depending claims 2-3, 5, 7-8, 11-12, and 14 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-5, 7-9, and 11-14 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 6, and 10 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using d) a server system/a plurality of peer group systems, wherein each peer group system comprises: (from claim 10) d1) a server comprising a server processor, a memory and a database, wherein the server is in communication with servers of other peer group systems, (from claim 10) and d2) a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: (from claim 10) a) a processor/an analyzer processor, b) measurement hardware in communication with the processor/analyzer processor and configured to generate electronic measurement signals from an analyte, and c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations to perform the claimed steps.
The claims also include the additional element steps of 6) “wherein all comparisons and re-evaluations are automatically performed without human intervention” and 13) “wherein all operations are executed by the processor and are not performed manually”.
The d) a plurality of peer group systems, wherein each peer group system comprises: d1) a server comprising a processor, a memory and a database, wherein the server is in communication with servers of other peer group systems, and d2) a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: a) a processor, b) measurement hardware in communication with the processor and configured to generate electronic measurement signals from an analyte, and c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations in these steps and the additional element step of 6) “wherein all comparisons and re-evaluations are automatically performed without human intervention” and 13) “wherein all operations are executed by the processor and are not performed manually” are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, paragraphs [0028] – [0031] where there are generic computing component for these components, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using d) a server system/a plurality of peer group systems, wherein each peer group system comprises: (from claim 10) d1) a server comprising a server processor, a memory and a database, wherein the server is in communication with servers of other peer group systems, (from claim 10) and d2) a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: (from claim 10) a) a processor/an analyzer processor, b) measurement hardware in communication with the processor/analyzer processor and configured to generate electronic measurement signals from an analyte, and c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations to perform the claimed steps and the additional element steps of 6) “wherein all comparisons and re-evaluations are automatically performed without human intervention” and 13) “wherein all operations are executed by the processor and are not performed manually” amount to no more than mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(f) recites that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention reports values to a user utilizing d) a server system/a plurality of peer group systems, wherein each peer group system comprises: (from claim 10) d1) a server comprising a server processor, a memory and a database, wherein the server is in communication with servers of other peer group systems, (from claim 10) and d2) a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: (from claim 10) a) a processor/an analyzer processor, b) measurement hardware in communication with the processor/analyzer processor and configured to generate electronic measurement signals from an analyte, and c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations and the additional element steps of 6) “wherein all comparisons and re-evaluations are automatically performed without human intervention” and 13) “wherein all operations are executed by the processor and are not performed manually”, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-14 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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